Pilot Study-Magnetic Resonance Imaging for Global Atherosclerosis Risk Assessment
NCT ID: NCT02265250
Last Updated: 2020-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2014-09-30
2024-10-31
Brief Summary
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Detailed Description
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During the first visit, the investigators will obtain non-contrast MRI (carotid, coronary, and femoral) in 20 subjects with known coronary atherosclerosis but varying degrees of CVD risk.
1. 5 asymptomatic subjects with lower CVD risk (recent coronary artery calcium score \[CACS\] 10-299)
2. 5 asymptomatic subjects with higher CVD risk (CACS 300-1000)
3. 5 subjects with known coronary atherosclerosis and stable angina
4. 5 subjects with known atherosclerosis and recent acute myocardial infarction
The investigators will measure plaque volume and assess adverse plaque features (intra-plaque hemorrhage, positive remodeling, lesion eccentricity) in the three vascular beds.
Eight of these subjects with evidence of large plaque burden by MRI will be asked to return for a simultaneous positron emission tomography (PET)-MRI imaging with 18F-sodium fluoride (18F-NaF) of their carotid, coronary, and femoral arteries, in which 18F-NaF uptake in plaque will represent micro-calcifications, which is associated with high-risk plaque.
In all 20 subjects, the investigators will also measure the following biomarkers which have been shown to be useful for CVD risk assessment of atherosclerosis: LDL, HDL, lipoprotein(a), apolipoprotein B/A-1 ratio, hemoglobin A1c, adiponectin, and highly sensitive C-reactive protein. The investigators will also calculate their estimated 10-year and lifetime atherosclerotic CVD risk (American Heart Association), Framingham 10-year CVD risk, and Reynolds 10-year CVD risk scores.
We aim to obtain the second scan within 3 months of the first visit; thus, the subjects will participate in the study for approximately 3 months.
All the procedures are research-related. The research visit will take approximately 3 hours, and there will be maximum two visits. There are no collaborations with other sites.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Asymptomatic, CACS <300
5 asymptomatic subjects with low CVD risk, defined as recent coronary artery calcium score (CACS) \<300
Noncontrast MRI of the bilateral carotid, coronary, and superficial femoral arteries; Laboratory blood test (cardiovascular biomarkers)
MRI
Noncontrast T1- and T2-weighted 3.0 T MRI of the bilateral carotid, coronary, and superficial femoral arteries
Laboratory blood test
Cardiovascular biomarkers
Asymptomatic, CACS ≥300
5 asymptomatic subjects with increased CVD risk, defined as a recent coronary artery calcium score (CACS) ≥300
Noncontrast MRI of the bilateral carotid, coronary, and superficial femoral arteries; Laboratory blood test (cardiovascular biomarkers); Simultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries
MRI
Noncontrast T1- and T2-weighted 3.0 T MRI of the bilateral carotid, coronary, and superficial femoral arteries
PET/MRI
Simultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries
Laboratory blood test
Cardiovascular biomarkers
Stable angina
5 subjects with stable angina and evidence of coronary atherosclerosis based on a recent invasive or CT coronary angiogram
Noncontrast MRI of the bilateral carotid, coronary, and superficial femoral arteries; Laboratory blood test (cardiovascular biomarkers); Simultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries
MRI
Noncontrast T1- and T2-weighted 3.0 T MRI of the bilateral carotid, coronary, and superficial femoral arteries
PET/MRI
Simultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries
Laboratory blood test
Cardiovascular biomarkers
Recent acute MI
5 subjects with a recent acute myocardial infarction (within 1 month) and evidence of coronary atherosclerosis based on invasive or CT coronary angiogram
Noncontrast MRI of the bilateral carotid, coronary, and superficial femoral arteries; Laboratory blood test (cardiovascular biomarkers); Simultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries
MRI
Noncontrast T1- and T2-weighted 3.0 T MRI of the bilateral carotid, coronary, and superficial femoral arteries
PET/MRI
Simultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries
Laboratory blood test
Cardiovascular biomarkers
Interventions
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MRI
Noncontrast T1- and T2-weighted 3.0 T MRI of the bilateral carotid, coronary, and superficial femoral arteries
PET/MRI
Simultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries
Laboratory blood test
Cardiovascular biomarkers
Eligibility Criteria
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Inclusion Criteria
2. No planned revascularization procedures
Exclusion Criteria
2. Pregnant and lactating women
3. Body mass index (BMI)\>40
4. Active smoking
5. Resting heart rate\>75 beats per minute
6. Arrhythmia
7. Prior carotid/coronary/peripheral revascularization
8. Life expectancy \<5 years
9. Allergy to animal dander
10. Severe asthma
18 Years
ALL
No
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Janet Wei
Co-Principal Investigator
Principal Investigators
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Janet Wei, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Noel Bairey Merz, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pro00037025
Identifier Type: -
Identifier Source: org_study_id
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